Skip to content

Clearfil Majesty Esthetic

by Kuraray Medical, Inc. 510(k)

Active United States

510(k) K061860

Overview

The Clearfil Majesty Esthetic is a light-curing, nano-superfilled, radiopaque restorative posterior composite resin (Product Code: EBF). It is designed for dental restorations, incorporating nano and micro inorganic fillers with a proprietary surface coating to enhance performance and aesthetics in posterior teeth.

This composite is supplied as a dental restorative material for use in clinical settings by dental professionals. It is intended for single-use applications and requires proper handling and storage as per manufacturer guidelines. The device holds FDA 510K clearance (K061860) under the Dental advisory committee, adhering to traditional review standards.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK061860 Date18 Sep 2006ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
EBF
Device Class
Class II
Regulation
21 CFR Part 872.3690
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Other devices from Kuraray Medical, Inc.

See all devices from Kuraray Medical, Inc. →

Questions

  • What types of dental restorations is the Clearfil Majesty Esthetic composite designed for, and why is it considered suitable for posterior teeth?

    The Clearfil Majesty Esthetic is specifically formulated for posterior dental restorations, meaning it is intended for molars and premolars. Its nano-superfilled composition, combined with radiopacity and a proprietary surface coating, enhances its mechanical strength, durability, and aesthetic properties—making it well-suited for areas requiring long-term wear resistance while maintaining a natural appearance.

  • Is the Clearfil Majesty Esthetic composite intended for reuse, or is it meant to be used only once per application?

    The Clearfil Majesty Esthetic is explicitly designed for single-use applications. This ensures sterility and consistency in performance, as each application is intended to be used once per patient visit, reducing the risk of contamination or degradation over multiple uses.

  • How is the Clearfil Majesty Esthetic composite supplied, and what storage conditions should be followed to maintain its integrity?

    The Clearfil Majesty Esthetic is supplied as a dental restorative material for clinical use by dental professionals. While the exact packaging details aren’t specified, most dental composites require storage in a cool, dry place, protected from direct sunlight and extreme temperatures. The manufacturer’s guidelines should be followed to ensure the material remains effective until use.

  • What does the FDA 510K clearance (K061860) under the Dental Advisory Committee mean for clinicians using this product?

    The FDA 510K clearance (K061860) indicates that the Clearfil Majesty Esthetic has been reviewed and deemed substantially equivalent to a legally marketed predicate device under traditional review standards by the Dental Advisory Committee. This means it meets FDA safety and effectiveness requirements for use as a restorative composite in posterior teeth, though clinicians should always refer to the manufacturer’s instructions for proper application.